Recently, MTPConnect was fortunate to play host to Frank Jasulke, Vice President and Head of Medical Alley Starts at Medical Alley who had travelled for a whirlwind tour of Australia from Minnesota, USA.

In Perth, RSM Australia was privileged to host MTPConnect and Frank, who provided a thought-provoking and inquisitive presentation on preparing to enter the US market for Health, Medical and Life Sciences (‘Biotechnology’) businesses.

For Australian startup companies in these sectors that are considering the strategic direction to enter the US market, the message is simple, “don’t assume the US market is like your market.”start-up insights

There were a number of key and critical criteria that Frank elucidated to the audience:

  • Fall in love with the problem and not the solution – i.e. be ready to pivot to ensure your products/solutions are fit for the market problem you are trying to solve;
  • Validate your problem, solution and market before launch;
  • Don’t discount the cost of change. If your product/solution requires someone to change workflow, behaviour or practice, you will encounter difficulty;
  • Learn what actually matters to your stakeholders, it may not be what you assume;
  • Understand the market focus, for example, doctors don’t buy a platform, they buy a solution to the problem; and
  • Learn and understand intimately the reimbursement (insurance) pathways before you enter the US market. There are over 1,100 insurers in the US, if your product won’t be eligible for reimbursement, strongly reconsider entering the US market.

Dr Rita Choueiri, Director in RSM Australia’s national R&D Tax and Incentives was also present to give insights into the Australian innovation, research and development community and how Australia is playing its part in the global realm:start-up industry and business insights

“With Australia being home to some of the world’s leading scientists and clinicians, world-class research capabilities and a sophisticated biotech sector, we are seeing an increase:

  • In our home developed therapeutics, diagnostics and technologies are being exported or snapped up by larger global pharma companies; and
  • A massive increase in the interest and enquires from global pharmaceutical companies in doing R&D in Australia, leading to ‘reverse osmosis’ where much more international companies are setting up an Australian presence to conduct R&D or commercialise IP in Australia.

For many companies looking to undertake clinical trials in Australia, the country’s efficient ethics and regulatory framework sets us apart from other countries because of:

  • Rapid entry to first-in-human studies with standards that are internationally recognised by both the Food and Drug Administration (FDA) and European Medicines Agency (EMA); andnew businesses news
  • The cost efficiencies gained for running clinical trials as a result of Australia’s generous R&D Tax Incentive (RDTI) program, access to R&D loans to improve cashflow position, potentially favourable exchange rates for international companies and/or reduced cost of labour compared to other western countries.”

Australia is home to an eclectic mix of startup and established Biotechnology businesses within an evolving community, that can leverage the generous Governmental support programs and strong regulatory frameworks for a sustained growth trajectory. Entering other world markets such as the US requires careful due diligence and planning. If positioned and targeted correctly, perhaps (hopefully!) Australia will see its next unicorn(s) on the world stage from the exciting Biotechnology sector!

FOR MORE INFORMATION

Please reach out to your local RSM Australia office if you have any questions or require further information.

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